A Post-Approval Study of the LINX® Reflux Management System

N/ACompletedNCT01940185

Torax Medical Incorporated200 enrolled

Overview

A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

LINX deviceDEVICE

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is a candidate for treatment with the LINX Reflux Management System * Patient has provided written informed consent for participation in the post-approval study. * Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments. * Patient has been diagnosed with GERD as defined by abnormal pH testing. * Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux. Exclusion Criteria: * Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials. * Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.

Locations (19)

Keck Medical Center of Univeristy of Southern California

Los Angeles, California, United States

University of California San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

Reduction of total GERD-HRQL score

Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.

Time frame: 6 months, 12 months, and annually to 60 months

Serious, device-related adverse events

Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted.

Time frame: 60 months

Secondary Outcomes

Related Adverse Events

Incidence rate of of device- and/or procedure-related adverse events

Time frame: 120 months

pH Measurements

Reduction from baseline in Total % time esophageal pH\<4

Time frame: The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)

Reduction of Symptoms

Reduction from baseline on Foregut Symptom Questionnaire (frequency and severity of heartburn and regurgitation, extra-esophageal symptoms and side effect profile). No formal statistical hypothesis tests will be conducted. Any statistical analyses will be primarily descriptive.

Time frame: The secondary measurements will be evaluated at yearly interval to 120 months

Data from ClinicalTrials.gov

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